FSD Pharma Inc (NASDAQ:HUGE) (CSE:HUGE.CN) (FRA:0K9A) announced on Monday that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for the use of its lead candidate FSD-201, or anti-inflammatory ultra-micronized-palmitoylethanolamide (PEA), to treat coronavirus (COVID-19) patients.
The company said that “severe COVID-19” is characterized by an “over-exuberant inflammatory response” that may lead to a cytokine storm and ultimately death. FSD Pharma is developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.
The trial will be a randomized, controlled, double-blind, US multicenter study at 25 to 30 sites, to assess the effectiveness and safety of FSD-201 dosed at 600 mg or 1,200 mg twice-daily, together with standard of care (SOC), versus SOC alone in hospitalized patients with documented COVID-19.
“The exploratory endpoint is cytokine clearance as measured by Enzyme Linked Immunosorbent Assay (ELISA),” the company said in a statement.
Separately, FSD said the company’s board has authorized the dispersion of an additional 369,255 class B subordinate voting shares to CEO Raza Bokhari and certain directors, officers, employees and consultants as share-based compensation.
Dr Bokhari received 805,802 Class B shares instead of cash compensation for his services as CEO. As a result, Dr Bokhari now owns around 8.5% of the issued and outstanding Class B shares. Dr Bokhari also continues to hold 33.3% of the group's outstanding class A multiple voting shares, and, in aggregate, he controls around 23% of the voting rights linked to FSD Shares.
The company noted that Dr Bokhari acquired the Class B Shares for “investment purposes" and has "no present intention" to sell the securities.
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